The present invention relates to methods of treating onychomycosis employing compositions with urea as the active ingredient. The present invention also finds new uses for urea as an antifungal agent. Onychomycosis refers to a fungal infection of the nail unit, defined as the nail matrix, bed or plate.
Urea has been long recognized as a cosmetic ingredient in formulations acting as a humectant and moisturizer. High concentrations of urea, such as 40%, are also known to have mild, antibacterial effect. At these strengths the antibacterial effects are said to be similar to those of antibiotics, with the further advantage that all the common organisms are susceptible and the possibility of resistant strains need not be seriously considered. There have been reports of keratolytic activity attributed to urea with the ability at high concentrations to solubilize and denature protein. Dermatological compositions containing from 21 to 40 wt-% urea for treating dry scaly skin have been described in U.S. Pat. No. 5,919,470.
Concentrated solutions of urea can change the conformation of protein molecules. A striking effect is upon the water-binding capacity of the horny layer of the skin: pieces of normal horny layer, or scales from ichthyotic or psoriatic skin that have been soaked in 30% urea solution take up much more water. This is important because in maintaining the flexibility of the horny layer and the softness of the skin, the water content of the horny layer matters much more than its oil content.
Fungal infections of the nail are notoriously difficult to treat. Traditional, topical therapies cannot penetrate the nail plate, and eradicate the infection in and under the nail bed; they are useful only in milder forms of the disease. Systemic antifungal drug therapy is associated with potentially harmful side effects. Since oral antifungals are distributed throughout the entire body, systemic side effects such as elevated liver enzymes, gastrointestinal disorders and skin rashes are not uncommon and may require expensive medical intervention and laboratory tests.
Topical formulations for treating fungal infections, such as onychomycosis, have recently been described in U.S. Pat. No. 6,281,239B1. The method employs the use of a combination of a known antifungal agent and a tissue softening composition containing 30 to 60 wt-% urea.
The present invention relates to methods of treating onychomycosis employing compositions containing urea as the antifungal agent. The present invention relates to methods for treating onychomycosis in humans with urea. These methods include topically administrating to the nail area of a human a safe and effective amount of urea. Onychomycosis refers to a fungal infection of the nail unit, defined as the nail matrix, bed or plate.
Accordingly, the present invention is a method for treating onychomycosis by topically administering a safe and effect amount of urea in a pharmaceutically acceptable carrier.